Parkinson DiseaseNCT03687203
Cognitive-driven ADL Impairment as a Predictor for PDD
An observational study of Parkinson Disease, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Mild cognitive impairment in Parkinson's disease (PD-MCI) is the highest risk factor for Parkinson's disease dementia (PDD). The core feature for differentiating PDD from PD-MCI is the loss of the ability to perform activities of daily living (ADL). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Functional Activities Questionnaire
- How many people
- 182 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jul 2018to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants of the already recruited ABC-PD (Amyloid-Beta in cerebrospinal fluid as a risk factor for cognitive dysfunction in Parkinson's Disease) cross-sectional cohort (Ethic Protocol of the Medical Faculty Tuebingen 686/2013B01) will be asked to participate in the follow-up assessment. A drop-out rate of 20% is expected for follow-up retention. Therefore, investigation of 209 patients will be conducted between August 2018 and April 2020.
Who may be able to join
- Participation in the baseline assessment
- Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
- Provide written informed consent to participate in the study and understand their right to withdraw consent at any time without prejudice to future medical care.
Who cannot join
- Any disability that may prevent the subject from completing the informed consent form or other study requirements.
- Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study.
- Participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and for any other limitation of participation based on local regulations.
- Alcohol, medication or drug dependency or abuse (except for nicotine).
- History of brain disease other than PD, e.g. head trauma, stroke, encephalitis, etc.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University hospital of Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Cognitive-driven ADL Impairment as a Predictor for Parkinson's Disease Dementia (PDD)
Mild cognitive impairment in Parkinson's disease (PD-MCI) is the highest risk factor for Parkinson's disease dementia (PDD). The core feature for differentiating PDD from PD-MCI is the loss of the ability to perform activities of daily living (ADL). As Parkinson's Disease (PD) is primarily a movement disorder, the distinction between motor and cognitive contributions to ADL in PD is an obvious challenge, which the investigators aimed to explore in this study. The goal of the study is to evaluate whether PD-MCI patients with more pronounced, cognitive-driven ADL impairment are at higher risk for cognitive worsening and PDD. A longitudinal follow-up assessment of 262 non-demented PD patients will be conducted over the next two years, with a comprehensive clinical assessment as well as biomarker sampling (cerebrospinal fluid and blood markers). Primary longitudinal outcome will be conversion to PDD and PD-MCI. Conversion rates of patients with and without additional mild cognitive-driven ADL impairment at baseline will be compared. Novel scores of the Pfeffer Functional Activities Questionnaire (FAQ) are used to assess instrumental ADL, differentiating between cognitive- and motor-driven ADL impairment in PD-MCI.
- Conditions
- Parkinson Disease
- Being tested
- Functional Activities Questionnaire
- Keywords
- Activity of daily living function, Cognitive impairment, Parkinson's disease dementia
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Activities QuestionnaireDiagnostic test
The FAQ is an economic and easy to apply activity of daily living scale. We aim to validate the prognostic value of novel FAQ scores, which differentiate cognitive- from motor-driven activity of daily living function.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Activity Questionnaire
Assessment of cognitive- and motor driven activity of daily living function
Measured: 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start20 Jul 2018
- Primary completion15 Oct 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Sub-Investigator, Dr. Kathrin Brockmann, University Hospital of Tuebingen, Tuebingen, Germany, Advisory board, Prof. Dr. Thomas Gasser, University Hospital of Tuebingen, Tuebingen, Germany, Advisory board, Prof. Dr. Berg, Christian-Albrechts-University, Kiel, Germany
- Responsible party
- Principal investigator, PD Dr. Inga Liepelt-Scarfone, University Hospital Tuebingen
- Investigators
- Inga Liepelt-Scarfone, PhD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687203
- Sponsor's protocol ID
- 284/2018BO1
- Status last verified
- Jan 2021
- First submitted
- 20 Sep 2018
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Becker S, Bode M, Brockmann K, Gasser T, Michaelis K, Solbrig S, Nuerk HC, Schulte C, Maetzler W, Zimmermann M, Berg D, Liepelt-Scarfone I. Cognitive-Driven Activities of Daily Living Impairment as a Predictor for Dementia in Parkinson Disease: A Longitudinal Cohort Study. Neurology. 2022 Dec 5;99(23):e2548-e2560. doi: 10.1212/WNL.0000000000201201.
PubMed 36240089
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-driven ADL Impairment as a Predictor for Parkinson's Disease Dementia (PDD)
- ClinicalTrials.gov ID
- NCT03687203
- Acronym / sponsor ID
- 284/2018BO1
- Conditions
- Parkinson Disease
- Keywords
- Activity of daily living function, Cognitive impairment, Parkinson's disease dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Sub-Investigator, Dr. Kathrin Brockmann, University Hospital of Tuebingen, Tuebingen, Germany, Advisory board, Prof. Dr. Thomas Gasser, University Hospital of Tuebingen, Tuebingen, Germany, Advisory board, Prof. Dr. Berg, Christian-Albrechts-University, Kiel, Germany
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild cognitive impairment in Parkinson's disease (PD-MCI) is the highest risk factor for Parkinson's disease dementia (PDD). The core feature for differentiating PDD from PD-MCI is the loss of the ability to perform activities of daily living (ADL). As Parkinson's Disease (PD) is primarily a movement disorder, the distinction between motor and cognitive contributions to ADL in PD is an obvious challenge, which the investigators aimed to explore in this study. The goal of the study is to evaluate whether PD-MCI patients with more pronounced, cognitive-driven ADL impairment are at higher risk for cognitive worsening and PDD. A longitudinal follow-up assessment of 262 non-demented PD patients will be conducted over the next two years, with a comprehensive clinical assessment as well as biomarker sampling (cerebrospinal fluid and blood markers). Primary longitudinal outcome will be conversion to PDD and PD-MCI. Conversion rates of patients with and without additional mild cognitive-driven ADL impairment at baseline will be compared. Novel scores of the Pfeffer Functional Activities Questionnaire (FAQ) are used to assess instrumental ADL, differentiating between cognitive- and motor-driven ADL impairment in PD-MCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the already recruited ABC-PD (Amyloid-Beta in cerebrospinal fluid as a risk factor for cognitive dysfunction in Parkinson's Disease) cross-sectional cohort (Ethic Protocol of the Medical Faculty Tuebingen 686/2013B01) will be asked to participate in the follow-up assessment. A drop-out rate of 20% is expected for follow-up retention. Therefore, investigation of 209 patients will be conducted between August 2018 and April 2020.
Key inclusion criteria (3 listed)
- Participation in the baseline assessment
- Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
- Provide written informed consent to participate in the study and understand their right to withdraw consent at any time without prejudice to future medical care.
Key exclusion criteria (5 listed)
- Any disability that may prevent the subject from completing the informed consent form or other study requirements.
- Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study.
- Participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and for any other limitation of participation based on local regulations.
- Alcohol, medication or drug dependency or abuse (except for nicotine).
- History of brain disease other than PD, e.g. head trauma, stroke, encephalitis, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Activities QuestionnaireThe FAQ is an economic and easy to apply activity of daily living scale. We aim to validate the prognostic value of novel FAQ scores, which differentiate cognitive- from motor-driven activity of daily living function. | Diagnostic test | – |
Primary outcome
Functional Activity Questionnaire
Time frame: 8 minutes
Assessment of cognitive- and motor driven activity of daily living function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 36240089Becker S, Bode M, Brockmann K, Gasser T, Michaelis K, Solbrig S, Nuerk HC, Schulte C, Maetzler W, Zimmermann M, Berg D, Liepelt-Scarfone I. Cognitive-Driven Activities of Daily Living Impairment as a Predictor for Dementia in Parkinson Disease: A Longitudinal Cohort Study. Neurology. 2022 Dec 5;99(23):e2548-e2560. doi: 10.1212/WNL.0000000000201201.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inga Liepelt-Scarfone, PhD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Activity Questionnaire (time frame: 8 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03687203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.